Mindful Action for Pain (MAP)

Mindful Action for Pain: An Integrated Approach to Improve Chronic Pain Function

An emerging scientific model that has been applied to chronic pain is the psychological flexibility (PF) model. PF refers to the ability to behave consistently with one's values even in the face of unwanted thoughts, feelings, and bodily sensations such as pain. Acceptance and Commitment Therapy (ACT) is the best known treatment derived from the PF model and is as effective as the gold standard Cognitive Behavioral Therapy (CBT), but falls short on achieving meaningful changes in functional improvement. Although ACT was designed to impact PF, methods from different treatment approaches are also consistent with the model. An experiential strategy that holds promise for enhancing PF is formal mindfulness meditation, a practice used to train non-judgmental awareness and attention to present-moment experiences, which has never been tested within the PF model. There is compelling theoretical and empirical rationale that the mechanisms underlying formal mindfulness meditation will bolster PF processes and thereby can be applied to facilitate functional improvement. To test this, the principal investigator, has developed a novel 8-week group-based intervention, Mindful Action for Pain (MAP), which integrates formal mindfulness meditation with experiential methods from different evidence-based treatment approaches in accordance with the PF model. MAP is designed such that daily mindfulness meditation practice is used to develop the capacity to more completely utilize strategies to address the key psychosocial barriers (e.g., pain catastrophizing) to optimal functioning.

This CDA-2 project consists of two phases. Phase 1 (years 1 - 2) consists of using qualitative and quantitative methods to iteratively develop and refine MAP over the course of 4 MAP cycles (n = 20). Phase 2 (years 3 - 5) consists of a pilot RCT (n = 86) of MAP vs. CBT for chronic pain (CBT-CP) in order to establish feasibility of a future large-scale trial and estimate the preliminary impact of MAP. Functional improvement will be measured by reductions in pain interference (primary clinical outcome). Further, meditation adherence will be assessed to explore dose-response relationships with functional improvement, and objective measures of physical activity (actigraphy) will be captured to explore the psychophysical impact of MAP.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Mindful Action for Pain; Behavioral: Cognitive Behavioral Therapy for Chronic Pain

Detailed Description

Chronic pain, defined as persistent or episodic pain that does not resolve with treatment, affects up to 50% of Veterans, costs the nation between $560 and $635 billion dollars annually, and is associated with high rates of disability and low quality of life. According to the Veterans Health Administration (VHA), the goal of pain treatment is to improve physical and psychosocial functioning, emphasizing non-pharmacological approaches, such as psychosocial interventions, to target psychosocial factors that maintain disability. Unfortunately, the gold standard psychosocial intervention for chronic pain, Cognitive Behavioral Therapy (CBT), does not reliably produce meaningful increases in function.

An emerging scientific model that has been applied to chronic pain is the psychological flexibility (PF) model. PF refers to the ability to behave consistently with one's values even in the face of unwanted thoughts, feelings, and bodily sensations such as pain. Acceptance and Commitment Therapy (ACT) is the best known treatment derived from the PF model and is as effective as the gold standard CBT, but still falls short on achieving meaningful changes in functional improvement. Although ACT was designed to impact PF, methods from different treatment approaches are also consistent with the model. An experiential strategy that holds promise for enhancing PF is formal mindfulness meditation, a practice used to train non-judgmental awareness and attention to present-moment experiences, which has never been tested within the PF model. There is compelling theoretical and empirical rationale that the mechanisms underlying formal mindfulness meditation will bolster PF processes and thereby can be applied to facilitate functional improvement. To test this, the principal investigator, has developed a novel 8-week group-based intervention, Mindful Action for Pain (MAP), which integrates formal mindfulness meditation with experiential methods from different evidence-based treatment approaches in accordance with the PF model. MAP is designed such that daily mindfulness meditation practice is used to develop the capacity to more completely utilize strategies to address the key psychosocial barriers (e.g., pain catastrophizing) to optimal functioning.

This CDA-2 project consists of two phases. Phase 1 (years 1 - 2) consists of using qualitative and quantitative methods to iteratively develop and refine MAP over the course of 4 MAP cycles (n = 20). Phase 2 (years 3 - 5) consists of a pilot RCT (n = 86) of MAP vs. CBT for chronic pain (CBT-CP) in order to establish feasibility of a future large-scale trial and estimate the preliminary impact of MAP. Functional improvement will be measured by reductions in pain interference (primary clinical outcome). Further, meditation adherence will be assessed to explore dose-response relationships with functional improvement, and objective measures of physical activity (actigraphy) will be captured to explore the psychophysical impact of MAP.

Aim 1: Fully develop MAP in a population of Veterans with chronic pain (Phase 1).

Aim 2: Evaluate the feasibility of a future randomized efficacy trial of MAP vs. CBT-CP (Phase 2).

Hypothesis 1: MAP and CBT-CP will be feasible to deliver, as evidenced by attainment of recruitment goals, retention rates > 80%, and high credibility and expectancy ratings.

Aim 3: Estimate the preliminary impact of MAP and CBT-CP to determine if a future efficacy trial is warranted.

Examine changes in pain interference (a proxy for functional improvement and one of the most commonly measured outcomes in psychosocial intervention trials of chronic pain), pain acceptance, trait mindfulness, and pain catastrophizing, as well as patient satisfaction ratings, as indicators that MAP may be worthy of investigation in a future large-scale trial.

Exploratory Aim 1: Explore the relationship between meditation adherence and treatment outcomes.

There is growing evidence for a dose-response relationship between meditation practice and positive outcomes. Therefore, strategies to increase meditation adherence will be optimized (Phase 1) and the relationship between adherence as measured via daily diaries and outcomes will be assessed (Phase 2).

Exploratory Aim 2: Explore objective measures of physical activity at baseline and post-intervention as a potential future index of functional outcomes.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer S Salamat, BS; Phone Number: 5596 (858) 552-8585; Email: jennifer.salamat@va.gov

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161-0002
      • VA San Diego Healthcare System, San Diego, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Veteran
• Diagnosis of a chronic, non-terminal pain condition
• Pain most days (> 3 days/week) for at least 6 months
• Average pain severity and interference with enjoyment of life and/or general activity rated > 4/10 over the past week

Exclusion Criteria:

• Serious or unstable medical or psychiatric illness

  • (e.g., unmanaged psychosis, manic episode, or substance abuse within the past year) or psychosocial instability
  • (e.g., homelessness) that could compromise study participation
• Active suicidal ideation or history of suicide attempt within past 3 years
• Current participation in group psychotherapy for pain or any type of individual psychotherapy

• Changes to professionally delivered pain or mood treatments

  • (e.g., no discontinuation of a treatment; no increasing the dose of medication) one month preceding the baseline assessment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Mindful Action for Pain (MAP) Development; In the first arm, MAP will be fully developed.	Behavioral: Mindful Action for Pain; MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy and Dialectical Behavior Therapy.; Other Names: MAP
Active Comparator: MAP vs. CBT-CP; In the second arm, MAP will be compared to CBT-CP to establish feasibility of a larger, future trial.	Behavioral: Mindful Action for Pain; MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy and Dialectical Behavior Therapy.; Other Names: MAP; Behavioral: Cognitive Behavioral Therapy for Chronic Pain; CBT-CP is the current gold standard psychosocial intervention for chronic pain and will be compared to MAP in the second arm of the study.; Other Names: CBT-CP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Pain Inventory (BPI) Pain Interference Subscale Change	The BPI Pain Interference subscale consists of 7-items rated on a 0 - 10 scale that measures the degree to which pain interferes with various aspects of life, including mobility, social activities, and mood. Higher scores indicate higher levels of pain interference.	Baseline, weekly during treatment (i.e., weeks 1 - 8), and week 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic Pain Acceptance Questionnaire (CPAQ)	The CPAQ consists of 20-items rated on a 0 - 6 scale that measures the degree that patients have adjusted to pain as part of their identity and lifestyle. Higher scores indicate higher levels of pain acceptance.	Baseline and week 9
Five-Factor Mindfulness Questionnaire (FFMQ)	The FFMQ measure five facets of mindfulness: observing inner experience, describing experience, acting with awareness, non-judging of experience, and non-reactivity to inner experience. The FFMQ consists of 39-items rated on a 1 - 5 scale with higher scores indicating greater mindfulness.	Baseline and week 9
Pain Catastrophizing Scale (PCS)	The PCS consists of 13 items rated on 0 - 4 scale that measures the degree to which people experience an aversive orientation towards pain. Higher scores indicate higher levels of pain catastrophizing.	Baseline and week 9

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Meditation diaries	On these diaries, participants report the duration of meditation practice and what kind of practice (e.g., breathing, body scan).	Weekly during treatment (i.e., weeks 1 - 8) and week 9
Actigraphy	Participants will wear actiwatches for two 7-day periods at baseline and week 9 to measure average physical activity counts.	Baseline and week 9

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Matthew Herbert, PhD, VA San Diego Healthcare System, San Diego, CA

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2019
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): March 29, 2024

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 8, 2019
• First Posted (Actual): January 11, 2019

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Pain; Mindfulness Meditation; Psychological Flexibility
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: D2807-W; RX002807 (Other Grant/Funding Number: VA RR&D)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A data repository will be created upon completion of the study. Data obtained in this study that has scientific value to other qualified researchers will made available upon request. Interested researches will be able to access de-identified data through a Data Use Agreement.
• IPD Sharing Time Frame: Indefinitely
• IPD Sharing Access Criteria: February, 2024
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No